Bristol-Myers' Oral HCV Treatment Daklinza Gets EU Clearance


Good news flowed in at Bristol-Myers Squibb Company (BMY) from Europe with the European Commission (:EC) approving the biopharmaceutical company’s Daklinza as a combination therapy for treating adults infected with genotypes 1, 2, 3 and 4 of chronic hepatitis C virus (:HCV). Bristol-Myers stated in its press release that following the EC move Daklinza became the first NS5A complex inhibitor to gain approval in the EU.

The EC approval does not surprise us since the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (:CHMP) had backed the approval of the cocktail therapy earlier in the year. Approval of Daklinza in the EU has brought down the duration of HCV treatment to either 12 or 24 weeks from 48 weeks associated with interferon- and ribavirin-based regimens.

Following the clearance, Daklinza can be used in combination with other drugs including Gilead Sciences’ (GILD) high-flying HCV treatment Sovaldi. The combination of Daklinza and Sovaldi performed exceedingly well in clinical trials. The combination can be used to treat various types of HCV patients including those with advanced liver disease, genotype 3 and those who have not responded to treatment with protease inhibitors.

Daklinza in combination with Sunvepra received Japanese approval in July for treating patients suffering from the genotype 1 strain of HCV. Bristol-Myers is also looking to get Daklinza-based regimens approved in the U.S. (target date: Nov 30, 2014). Gilead’s HCV combination therapy of Sovaldi and ledipasvir is expected to be approved in the U.S. earlier (target date: Oct 10, 2014). AbbVie (ABBV) is also looking to bring its HCV combination therapy into the market. We expect investor focus to remain on updates related to HCV combination therapies going forward.

Bristol-Myers carries a Zacks Rank #3 (Hold). A better-ranked stock in the biopharma space is Celgene Corporation (CELG) holding a Zacks Rank #2 (Buy).

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